QMS Process Engineer
Roche
Summary
As QMS Process Engineer you will use your expertise to deliver operational excellence of specific "Critical-to-Quality" (CtQ) ecosystems by executing fit-for-purpose quality activities and driving the delivery and sustainability of a robust Quality Management System (QMS).
Job description
The Opportunity
As QMS Process Engineer you will use your expertise to deliver operational excellence of specific "Critical-to-Quality" (CtQ) ecosystems by executing fit-for-purpose quality activities and driving the delivery and sustainability of a robust Quality Management System (QMS).
- Partner across teams to design, implement, and optimize clear data-driven execution workflows.
- Integrate modern digital enablement, AI, and automation tools to streamline linear processes.
- Translate raw quality data into structured insights, performing trend analyses to identify actionable operational patterns.
- Maintain alignment with global regulatory standards (including GxP, Pharmacovigilance, and IVD/Medical Device regulations) to embed "Critical-to-Quality" principles into system design.
- Support inspection readiness and regulatory intelligence analysis to assess the impact of emerging regulations.
- Proactively engage with multi-disciplinary stakeholders to guide compliant, sustainable process updates.
Who You Are
- Education & Experience: Bachelor's degree in a scientific or quality-related field (or equivalent practical experience), with professional experience in a regulated GxP environment.
- Process Methodology: Strong foundational understanding of process engineering frameworks (such as Lean or Agile).
- Data & Digital Literacy: Skilled in data analytics and quality data storytelling, with experience using data to solve operational challenges and substantiate recommendations.
- Problem Solving & Ownership: Proactive self-starter who navigates ambiguity with critical thinking and takes ownership to bridge operational gaps.
- Collaboration & Influence: Strong communicator and relationship-builder with the ability to influence without formal authority and partner effectively across teams.
Requirements
- Bachelor's degree in a scientific or quality-related field (or equivalent practical experience)
- Professional experience in a regulated GxP environment
- Strong foundational understanding of process engineering frameworks (such as Lean or Agile)
- Skilled in data analytics and quality data storytelling
- Experience using data to solve operational challenges and substantiate recommendations
- Proactive self-starter who navigates ambiguity with critical thinking
- Strong communicator and relationship-builder with ability to influence without formal authority
Benefits
- Annual bonus
- Medical, Dental & Vision
Company overview
Roche is a Swiss multinational healthcare company and a global pioneer in pharmaceuticals and diagnostics, founded in 1896 and headquartered in Basel, Switzerland. As the world's largest biotech company and the fifth-largest pharmaceutical company by revenue, Roche operates through two primary divisions: Pharmaceuticals and Diagnostics. The company is renowned for its leadership in personalized healthcare, combining strengths in both drug development and diagnostic testing to deliver tailored treatments for patients. Roche maintains a strong focus on oncology, immunology, infectious diseases, ophthalmology, and central nervous system disorders, with a portfolio that includes over 30 medicines on the World Health Organization's Model Lists of Essential Medicines. The company owns significant subsidiaries including Genentech, Chugai Pharmaceuticals, Ventana Medical Systems, and Foundation Medicine. With approximately 103,000 employees worldwide and operations in over 100 countries, Roche has established itself as a leader in cancer treatments globally while maintaining a robust pipeline of innovative therapies and diagnostic solutions. The company's commitment to sustainability has been recognized through ten consecutive years as Group Leader in the Dow Jones Sustainability Indices within the Pharmaceuticals, Biotechnology & Life Sciences Industry.